April 9, 2007
Eurand announced positive results from two phase IIItrials of Zentase for the treatment of Exocrine Pancreatic Insufficiency(EPI). The first was a multi-center, double-blind, placebo-controlled,cross-over trial and enrolled 20 pediatric subjects aged seven and older. Thesecond was an open-label trial and enrolled pediatric subjects aged seven andyounger. In both trials subjects were treated with Zentase or placebo. Pooledresults from both trials showed an increase in the coefficient of fatabsorption (CFA), with a mean CFA percentage in the Zentase group of 88. 3%versus 62.8% in those receiving placebo (p<0.001). Zentase treatment alsoreturned CFA and coefficient of nitrogen absorption (CNA) levels to normalranges. In addition, the subjects on Zentase had fewer symptoms associated withimpaired absorption including bloating, flatulence, pain and evidence of fat instools. Based on the results, Eurand plans to file for FDA approval of Zentasefor both pediatric and adult populations in the second quarter of 2007.
October 31, 2005
Altus Pharmaceuticals reported positive results of a phase II trial of TheraCLEC (ALTU-135), for the treatment of cystic fibrosis patients with malabsorption due to pancreatic insufficiency, at the North American Cystic Fibrosis Conference in Baltimore. Trial data yielded statistically significant improvements in absorption of both dietary fat and protein (p<0.001), and additional improvements in carbohydrate absorption. The subset of patients with the lowest baseline absorption rates showed the greatest improvements. This dose-ranging, randomized, double-blind study enrolled 125 subjects across 26 sites in the US. The company announced that, based on these results, they had begun meetings with the FDA regarding the design of phase III trials of the drug.
June 9, 2003
Fujisawa Healthcare reported positive results from a post-marketing trial investigating Prograf in combination with Mycophenolate Mofetil (MMF) in pancreas-kidney transplant patients. Results show that subjects receiving induction therapy reported significantly higher kidney survival rate, (92.0%, vs. 81.6%) than those receiving no induction therapy. There was no difference in the pancreas survival rate between the two groups. The 3 year, randomized, multicenter study enrolled 174 subjects and was conducted to assess the effect of antibody induction in SPK transplantation patients receiving maintenance immunosuppression with Prograf, MMF and a steroid taper. Half the subjects received induction therapy and half did not. Results were presented at the 2003 American Transplant Congress.